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NCT Number: NCT06235645

dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

Rheumatoid arthritis is an autoimmune disease that can affect various organs, including the lungs, and lead to rheumatoid arthritis-interstitial lung disease (RA-ILD).

RA-ILD is responsible for increased mortality in rheumatoid arthristis (RA) patients.

The prevalence of RA-ILD varies according to the screening tool used.

The current gold standard is chest CT, but this is an expensive, time-consuming and irradiating examination, and recommendations on when and how often it should be performed are not clearly established.

Lung ultrasound (LUS) is an emerging tool for the detection of lung parenchymal damage, particularly in systemic scleroderma and idiopathic pulmonary fibrosis (IPF).

LUS is a non-irradiating, non-expensive examination that can be performed rapidly.

The aim of our study is to evaluate LUS as a screening tool for RA-ILD, in patients with risk factors for developing RA-ILD.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

university hospital Tours

Tours, 37000, France

Location status: Recruiting

Location contact

Ariane MERLIN-DOMONT

CONTACT

[email protected]

Sylvie LEGUE

CONTACT

[email protected]

247479835 ext. +33

Sylvie LEGUE

PRINCIPAL_INVESTIGATOR

About this study

Patients with RA and who have risk factors for RA-ILD are regularly reassessed in a rheumatology day hospital.

As part of their routine follow-up, and given the absence of recommendations on screening for RA-ILD in this population, chest CT and PFT (pulmonary function tests) are regularly performed at the request of the rheumatologist.

Therefore, all patients meeting the inclusion criteria and having undergone chest CT and PFT in the 6 months preceding or following their rheumatology reassessment will be offered participation in the study.

Participation in the study does not alter the patient's usual follow-up.

Objective of the study: evaluate the sensitivity and specificity of thoracic ultrasound compare to the chest CT in patients with risk factors of developing RA-ILD.

Design: This is a non-interventional, prospective, single-center, multidisciplinary study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient (age > 18 years) followed at CHU of Tours
  • Diagnosis of rheumatoid arthritis validated according to ACR 2010 criteria, EULAR classification, regardless of time since diagnosis
  • Patient who has had or will have a thoracic CT scan and PFT performed as part of routine care in the 6 months preceding or following inclusion
  • Patient with at least two risk factors for developing RA-ILD among :
  • Male sex or
  • Active or former smoker assessed at 20 pack-year or
  • Age > 60 years or
  • Levels of RF≥3N (rheumatoid factor) and/or anti-CCP≥3N (antibodies against cyclic citrullinated peptides) at diagnosis or at any time during the course of the disease or
  • High RA activity score (DAS28>3.2)

Exclusion criteria

  • Diagnosis of congenital lung disease
  • Diagnosis of another autoimmune pathology associated with RA (overlap syndrome) linked to the development of ILD (interstitial lung disease) (systemic sclerosis, myositis, dermatomyositis, mixed connectivitis, systemic lupus erythematosus or other ANCA vasculitis, with the exception of secondary Gougerot-Sjögren's syndromes).
  • Current or operated lung cancer
  • Thoracic irradiation
  • Thoracic transplant patients
  • Previous invasive thoracic procedures
  • Pathologies responsible for pleural thickening (silicosis, asbestosis, known pleural plaque, pleural sequelae of tuberculosis)
  • Pregnant or breast-feeding women
  • Patient under legal protection (guardianship, curatorship or safeguard of justice)
  • Patient who has objected to data processing
  • Parenchymal infection current or less than one month old prior to LUS examination
  • Liquid or gaseous pleural effusion

Treatment and study plan

Lung Ultrasound (LUS)

Diagnostic Test

If included, an LUS will be performed by an experienced operator, blinded to the results of the chest CT and PFT.

A linear probe (4 to 12 MHz) will be used. The patient will be installed́ in a semi-seated position with the homolateral arm above the head for the anterior and axillary evaluation then, depending on his comfort, in a seated position or in right then left lateral decubitus, arms alongside the body, for the posterior evaluation. It will be practiced by experienced operators (pneumologist) and according to a validated protocol allowing the exploration of 14 intercostal spaces. LUT will be timed, recorded and anonymized.

The operator will note the 3 ultrasound signs (total number of B lines, pleural line thickening and percentage of pleural line irregularity), their location and severity.

The radiologist, on his part, will evaluate the patient's chest CT (gold standard), blinded to the results of the LUS, to make or not the diagnosis of RA-ILD.

Primary outcomes

  1. Determination sensitivity and specificity of thoracic ultrasound

    Time frame: 2 years

    The primary outcome is to determine the sensitivity and specificity of thoracic ultrasound defined as pathological by a total number of B lines ≥ 9 and/or pleural line thickening ≥ 3mm and/or a percentage of pleural line irregularity ≥ 24%.

Secondary outcomes

  1. Percentage of each of the 3 ultrasound signs among pathological ultrasounds.

    Time frame: 2 years

    The secondary outcome is the percentage of each of the 3 ultrasound signs among pathological ultrasounds.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariane MERLIN-DOMONT

CONTACT

[email protected]

Sylvie LEGUE

CONTACT

[email protected]

0247479835 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: EARLIER

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 1, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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